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A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01278407
First received: January 14, 2011
Last updated: December 30, 2015
Last verified: December 2015
Results First Received: October 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Dementia With Lewy Bodies (DLB)
Interventions: Drug: Donepezil 5 mg
Drug: Donepezil 10 mg
Drug: Donepezil matched placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.

Reporting Groups
  Description
Placebo - Confirmatory Phase Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
Donepezil 5 mg - Confirmatory Phase Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
Donepezil 10 mg - Confirmatory Phase Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
Placebo to Donepezil (5 +10 mg) - Extension Phase Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
Donepezil (5 +10 mg) - Extension Phase Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.

Participant Flow for 2 periods

Period 1:   Confirmatory Phase
    Placebo - Confirmatory Phase     Donepezil 5 mg - Confirmatory Phase     Donepezil 10 mg - Confirmatory Phase     Placebo to Donepezil (5 +10 mg) - Extension Phase     Donepezil (5 +10 mg) - Extension Phase  
STARTED     46     47     49     0     0  
COMPLETED     37     31     43     0     0  
NOT COMPLETED     9     16     6     0     0  
Adverse Event                 5                 10                 1                 0                 0  
Participant's Choice                 3                 5                 3                 0                 0  
Not Specified                 1                 1                 2                 0                 0  

Period 2:   Extension Phase
    Placebo - Confirmatory Phase     Donepezil 5 mg - Confirmatory Phase     Donepezil 10 mg - Confirmatory Phase     Placebo to Donepezil (5 +10 mg) - Extension Phase     Donepezil (5 +10 mg) - Extension Phase  
STARTED     0     0     0     46     96  
COMPLETED     0     0     0     34     66  
NOT COMPLETED     0     0     0     12     30  
Adverse Event                 0                 0                 0                 7                 16  
Participant's Choice                 0                 0                 0                 4                 11  
Not Specified                 0                 0                 0                 1                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The data is based on Full Analysis Set, defined as all the randomized patients who received the study drug at least once and had valid efficacy assessment data at more than one point.

Reporting Groups
  Description
Placebo - Confirmatory Phase Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
Donepezil 5 mg - Confirmatory Phase Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
Donepezil 10 mg - Confirmatory Phase Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
Total Total of all reporting groups

Baseline Measures
    Placebo - Confirmatory Phase     Donepezil 5 mg - Confirmatory Phase     Donepezil 10 mg - Confirmatory Phase     Total  
Number of Participants  
[units: participants]
  44     45     49     138  
Age  
[units: Years]
Mean (Standard Deviation)
  77.2  (6.1)     78.8  (5.1)     77.7  (6.8)     77.9  (6.1)  
Gender  
[units: participants]
       
Female     27     25     28     80  
Male     17     20     21     58  
Mini-Mental State Examination (MMSE) Score [1]
[units: Unit on a scale]
Mean (Standard Deviation)
  20.3  (4.2)     20.6  (4.1)     20.3  (4.8)     20.4  (4.3)  
[1] The score ranged from 0 to 30, with a higher score indicating better function.



  Outcome Measures
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1.  Primary:   Change From Baseline in Mini-Mental State Examination (MMSE) Score   [ Time Frame: Week 12 for Confirmatory Phase ]

2.  Primary:   Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score   [ Time Frame: Week 12 for Confirmatory Phase ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Masaki Nakagawa
Organization: Eisai Co., Ltd.
phone: +81-3-3817-5245 ext 5245



Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01278407     History of Changes
Other Study ID Numbers: E2020-J081-341
Study First Received: January 14, 2011
Results First Received: October 27, 2015
Last Updated: December 30, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare